NUVB

Nuvation Bio Announces Appointment of Colleen Sjogren as Chief Commercial Officer

Retrieved on: 
Thursday, March 28, 2024
Biotechnology, General Health, Health, Pharmaceutical, Oncology, NUVB, Janssen Pharmaceuticals, Mirati Therapeutics, Event, Medivation, Patient, Bryant University, Cancer, Senior, Kite Pharma, Sjögren, Marketing, Pharmaceutical industry

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the appointment of Colleen Sjogren as Chief Commercial Officer.

Key Points: 
  • Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the appointment of Colleen Sjogren as Chief Commercial Officer.
  • Ms. Sjogren will lead the Company’s commercial strategy and operations, including marketing, sales, and market access.
  • “We are thrilled to welcome Colleen as Nuvation Bio’s first Chief Commercial Officer.
  • Of note, Colleen was one of my commercial superstars at Medivation when we launched XTANDI®,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio.

Nuvation Bio to Acquire AnHeart Therapeutics in All-Stock Transaction

Retrieved on: 
Monday, March 25, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, NUVB, Morrison & Foerster, Partner, NMPA, Cayman Islands, Entrepreneurship, NSCLC, Patient, Conyers, Georgia, LLP, Haiwen & Partners, Acquisition, Cancer, Cooley LLP, Priority review, Fangda, Intellectual property, FDA, ROS1, Cayman, Food, Pharmaceutical industry

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, and AnHeart Therapeutics Ltd. (AnHeart), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced that the companies have entered into a definitive agreement for Nuvation Bio to acquire AnHeart in an all-stock transaction (the Acquisition).

Key Points: 
  • Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, and AnHeart Therapeutics Ltd. (AnHeart), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced that the companies have entered into a definitive agreement for Nuvation Bio to acquire AnHeart in an all-stock transaction (the Acquisition).
  • Immediately following the closing of the Acquisition, the former shareholders of AnHeart will own approximately 33% and the current stockholders of Nuvation Bio will own approximately 67% of Nuvation Bio on a fully diluted basis.
  • Subject to approval by the Nuvation Bio stockholders (the Nuvation Bio Stockholder Approval), each share of Series A Non-Voting Convertible Preferred Stock issued by Nuvation Bio in the Acquisition will initially be convertible into 100 shares of Class A common stock.
  • Any shareholders of AnHeart who are not accredited investors will receive cash for their AnHeart shares in lieu of receiving Nuvation Bio securities.

Nuvation Bio Doses First Patient in Phase 1/2 Study of NUV-1511 for the Treatment of Advanced Solid Tumors

Retrieved on: 
Thursday, March 14, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, NUVB, Safety, Therapy, Patient, Food and Drug Administration, FDA, PROC, DDC, Food, Pharmaceutical industry

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the first patient has been dosed in a Phase 1/2 study of NUV-1511, the Company’s first DDC to enter the clinic.

Key Points: 
  • Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the first patient has been dosed in a Phase 1/2 study of NUV-1511, the Company’s first DDC to enter the clinic.
  • “Dosing the first patient with NUV-1511 marks a significant milestone for our proprietary DDC platform, from which we are developing potent oncology-focused chimeric small molecules designed to selectively deliver anti-cancer therapeutics to cancer cells, while mitigating effects on healthy non-target tissues,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio.
  • “DDCs are the core technology upon which the Company was founded and we are excited to bring our first DDC clinical candidate to patients.”
    The dose escalation portion of the study employs a flexible design that allows for the potential to explore two dosing schedules for NUV-1511 with the goal of establishing the recommended Phase 2 dose.
  • The study will initially evaluate safety and tolerability, pharmacokinetic profile, and assess for signs of clinical activity in patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved U.S. Food and Drug Administration (FDA) labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), advanced pancreatic cancer, and platinum-resistant ovarian cancer (PROC).

Biotech's Role in Addressing the Pancreatic Cancer Emergency

Retrieved on: 
Thursday, March 14, 2024
Ovarian cancer, Immunotherapy, Patient, History, Lutetium (177Lu) oxodotreotide, IND, Cancer, NVS, NUVB, NCI, Novartis, Science, Colorectal cancer, Risk, American Cancer Society, FOLFIRINOX, PDAC, Pancreatic Cancer Action Network, Safety, Immune system, Interim, University, Translational research, Survival rate, Disease, Clinical professor, Associate, Tumor microenvironment, Death, TSX, Pancreatic cancer, Sunnybrook Health Sciences Centre, ACRS, FDA, DCP, Diagnosis, Entrepreneurship, Environment, Physician, Triple-negative breast cancer, Mortality, News, PROC, DDC, Hereditary nonpolyposis colorectal cancer, Optimism, ONC, Pharmaceutical industry

VANCOUVER, BC, March 14, 2024 /PRNewswire/ -- USA News Group - Known as one of the most deadly forms of cancer, pancreatic cancer still has the highest mortality rate of all major cancers today. However, researchers and the biotech sector are working diligently to improve the chances of those who receive this dire diagnosis. Recently, in late 2023, researchers at the Mayo Clinic made a discovery that advances knowledge of how pancreatic cancer spreads and identified a new potential therapeutic target along the way. With the American Cancer Society projecting a record year for new cancer cases in 2024, and Europe facing a pancreatic cancer emergency, it's important to focus on the advances being made in the biotech sector that are giving hope to patients and their families. Among the developers making gains include Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), ImmunityBio, Inc. (NASDAQ: IBRX), Aclaris Therapeutics, Inc. (NASDAQ: ACRS), and Nuvation Bio Inc. (NYSE: NUVB). 

Key Points: 
  • There is a point of optimism to build upon, as the Pancreatic Cancer Action Network (PanCAN) has stated the five-year survival rate for pancreatic cancer has increased to 13% .
  • "Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients."
  • It will focus on patients with pancreatic cancer, HER2-negative metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), and platinum-resistant ovarian cancer (PROC).
  • Nuvation is already undergoing dosing in the Phase 1 monotherapy study of NUV-868 in solid tumors in patients with pancreatic cancer, ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC), triple-negative breast cancer and other solid tumors.

Biotech's Role in Addressing the Pancreatic Cancer Emergency

Retrieved on: 
Thursday, March 14, 2024
Ovarian cancer, Immunotherapy, Patient, History, Lutetium (177Lu) oxodotreotide, IND, Cancer, NVS, NUVB, NCI, Novartis, Science, Colorectal cancer, Risk, American Cancer Society, FOLFIRINOX, PDAC, Pancreatic Cancer Action Network, Safety, Immune system, Interim, University, Translational research, Survival rate, Disease, Clinical professor, Associate, Tumor microenvironment, Death, TSX, Pancreatic cancer, Sunnybrook Health Sciences Centre, ACRS, FDA, DCP, Diagnosis, Entrepreneurship, Environment, Physician, Triple-negative breast cancer, Mortality, News, PROC, DDC, Hereditary nonpolyposis colorectal cancer, Optimism, ONC, Pharmaceutical industry

VANCOUVER, BC, March 14, 2024 /PRNewswire/ -- USA News Group - Known as one of the most deadly forms of cancer, pancreatic cancer still has the highest mortality rate of all major cancers today. However, researchers and the biotech sector are working diligently to improve the chances of those who receive this dire diagnosis. Recently, in late 2023, researchers at the Mayo Clinic made a discovery that advances knowledge of how pancreatic cancer spreads and identified a new potential therapeutic target along the way. With the American Cancer Society projecting a record year for new cancer cases in 2024, and Europe facing a pancreatic cancer emergency, it's important to focus on the advances being made in the biotech sector that are giving hope to patients and their families. Among the developers making gains include Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), ImmunityBio, Inc. (NASDAQ: IBRX), Aclaris Therapeutics, Inc. (NASDAQ: ACRS), and Nuvation Bio Inc. (NYSE: NUVB). 

Key Points: 
  • There is a point of optimism to build upon, as the Pancreatic Cancer Action Network (PanCAN) has stated the five-year survival rate for pancreatic cancer has increased to 13% .
  • "Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients."
  • It will focus on patients with pancreatic cancer, HER2-negative metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), and platinum-resistant ovarian cancer (PROC).
  • Nuvation is already undergoing dosing in the Phase 1 monotherapy study of NUV-868 in solid tumors in patients with pancreatic cancer, ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC), triple-negative breast cancer and other solid tumors.

Nuvation Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 29, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Research, FDA, MTD, DDC, Ovarian cancer, Patient, Tax, Pancreatic cancer, IND, NUVB, Insurance, Cryptocurrency

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Nuvation Bio has completed the Phase 1 monotherapy study in advanced solid tumors and determined the MTD in patients.
  • As of December 31, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $611.2 million.
  • For the three months ended December 31, 2023, Nuvation Bio reported a net loss of $13.8 million, or $(0.06) per share.

Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-1511 for the Treatment of Advanced Solid Tumors

Retrieved on: 
Monday, January 8, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, PROC, Patient, Safety, Food, NUVB, DDC, Pancreatic cancer, IND

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-1511, the first clinical candidate from the company’s novel drug-drug conjugate (DDC) platform.

Key Points: 
  • Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-1511, the first clinical candidate from the company’s novel drug-drug conjugate (DDC) platform.
  • “This IND clearance expands our clinical pipeline and validates the approach of our proprietary DDC platform to design potent oncology-focused chimeric small molecules which combine tumor-targeting specificity with the anti-cancer activity of known oncology agents,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio.
  • “We believe NUV-1511 has the potential to provide favorable clinical benefit for patients with various solid tumors and we look forward to initiating the Phase 1/2 study.”
    The dose escalation portion of the Phase 1/2 study will initially evaluate safety and tolerability, and explore the potential for clinical efficacy, in patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved FDA labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), pancreatic cancer, and platinum-resistant ovarian cancer (PROC).

Nuvation Bio Announces Appointment of Dr. Robert Mashal to its Board of Directors

Retrieved on: 
Monday, January 8, 2024
Biotechnology, General Health, Health, Pharmaceutical, Oncology, Boston Millennia Partners, University, NUVB, Immunology, Internal medicine, McKinsey & Company, Johns Hopkins University, Therapy, Vertex Pharmaceuticals, NKT, Pharmaceutical industry

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the appointment of Robert Mashal, M.D.

Key Points: 
  • Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the appointment of Robert Mashal, M.D.
  • “We are delighted to have Dr. Mashal join our Board of Directors,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio.
  • “Robert is a seasoned biotech industry veteran and his experience as an investor, operator, and medical oncologist will provide us with valuable insights.
  • We look forward to working with Robert to advance Nuvation’s pipeline.”
    “Nuvation Bio is at the forefront of developing therapeutic candidates to treat the unmet need in oncology, highlighted by the company’s novel drug-drug conjugate platform,” said Robert Mashal, M.D.

Nuvation Bio Announces Departure of Chief Financial Officer

Retrieved on: 
Monday, November 13, 2023
Biotechnology, Pharmaceutical, Health, Oncology, NUVB, NYSE, CFO, Management

Nuvation Bio Inc. (NYSE: NUVB) (the “Company”) announced today that Jennifer Fox will be stepping down from her role as Chief Financial Officer to pursue a new opportunity.

Key Points: 
  • Nuvation Bio Inc. (NYSE: NUVB) (the “Company”) announced today that Jennifer Fox will be stepping down from her role as Chief Financial Officer to pursue a new opportunity.
  • Ms. Fox submitted her resignation on November 9, 2023 with an effective date of November 27, 2023.
  • Members of the executive management team and the Company’s finance team will assume the duties and responsibilities of the CFO office.
  • “Jen has played an integral role in helping to set the strategic and financial direction for Nuvation Bio, and I want to thank her for her dedication and hard work in moving Nuvation Bio forward,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio.

Nuvation Bio Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 2, 2023
Oncology, Health, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Insurance, DDC, Investigational New Drug, IND, Patient, NYSE, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Ovarian cancer, NUVB, Food, Pancreatic cancer, Research, Pharmaceutical industry, Cryptocurrency

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported its financial results for the third quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported its financial results for the third quarter ended September 30, 2023, and provided a business update.
  • Nuvation Bio remains on track to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023.
  • As of September 30, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $619.3 million.
  • For the three months ended September 30, 2023, Nuvation Bio reported a net loss of $19.6 million, or $(0.09) per share.